BREVIBLOC 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Brevibloc 10 mg/ml Solution for Infusion

Esmolol Hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

In this leaflet, BREVIBLOC 10 mg/ml Solution for Infusion will be referred to as Brevibloc.

Contents of the Package Leaflet:

1. What is Brevibloc and what is it used for
2. What you need to know before you are given Brevibloc
3. How Brevibloc will be given to you
4. Possible side effects
5. Storage of Brevibloc
6. Contents of the pack and other information

1. What is Brevibloc and what is it used for

Brevibloc contains a medicine called esmolol. It belongs to a group of medicines called “beta-blockers”. It works by controlling the frequency and strength of your heartbeats. It may also help you to reduce blood pressure.

It is used to treat the following:

• Heart rate problems, if it is too fast
• Heart problems and high blood pressure if they occur during or just after an operation.

2. What you need to know before you are given Brevibloc

Your doctor will not give you Brevibloc if:

• You are allergic (hypersensitive) to esmolol, any other beta-blocker medicine, or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include difficulty breathing, wheezing, rash, itching, or swelling of the face and lips.
• You have a very low heart rate (less than 50 beats per minute).
• Your heart rate is high or alternates between low and high.
• You have what is called a “severe heart block”; this is a problem with the electrical impulses that control your heart rate.
• You have low blood pressure.
• You have problems with blood flow to the heart.
• You have severe symptoms of heart failure.
• You are receiving or have recently received verapamil. You should not be given Brevibloc within 48 hours of your last dose of verapamil.
• You suffer from a glandular disease called phaeochromocytoma that has not been treated. Phaeochromocytoma occurs in the adrenal gland and can cause a sudden increase in blood pressure, severe headaches, sweating, and increased heart rate.
• You have high blood pressure in the lungs (pulmonary hypertension).
• You have asthma symptoms that worsen quickly.
• You have high levels of acid in the body (metabolic acidosis).

You will not be given Brevibloc if you have any of the above problems. If you are not sure if you have any of these conditions, talk to your doctor, pharmacist, or nurse before using Brevibloc.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Brevibloc. Your doctor will be especially careful with this medicine if:

• You are being treated for certain heart rhythm disorders called supraventricular arrhythmias and:
• • you have other heart problems or
  • you are taking other heart medicines.

Using Brevibloc in this way can cause side effects that can be fatal, including:

• loss of consciousness
• shock (if your heart does not pump enough blood)
• heart attack (cardiac arrest)

• You develop low blood pressure (hypotension). This can be noticed in symptoms such as dizziness or feeling faint, especially when standing up. Low blood pressure usually improves 30 minutes after stopping treatment with Brevibloc.
• You have a low heart rate before treatment.
• Your heart rate decreases to less than 50 or 55 beats per minute. If this happens, your doctor may give you a lower dose or stop treatment with Brevibloc.
• You have heart failure.
• You have a problem with the electrical impulses that control your heart rate (heart block).
• You suffer from a glandular disease called phaeochromocytoma that has been treated with medicines called “alpha-blockers”.
• You are being treated for high blood pressure caused by low body temperature (hypothermia).
• You have narrowing of the airways or wheezing, such as those characteristic of asthma.
• You have diabetes or low blood sugar levels. Brevibloc can increase the effects of diabetes medicines.
• You develop skin problems, which can be caused by leaks of solution around the injection site. If this happens, your doctor will use a different vein for the injection.
• You have a certain type of chest pain (angina) called “Prinzmetal's angina”.
• You have low blood volume. You may develop low blood pressure (hypotension) more easily
• You have circulation problems, such as pale fingers (Raynaud's disease) or pain, tiredness, and sometimes a burning sensation in the legs.
• You have kidney problems. If you have kidney failure or need dialysis, you may have increased potassium levels in the blood (hyperkalemia), which can cause serious heart problems
• You have any allergies or are at risk of anaphylactic reactions (severe allergic reactions). Brevibloc can worsen allergies and make them more difficult to treat.
• You or a family member has psoriasis (skin that produces scales)
• You have a disease called hyperthyroidism (overactive thyroid gland)

It is not usually necessary to change the dose if you have liver problems.

If any of the above conditions apply to you (or if you are not sure), talk to your doctor, pharmacist, or nurse before you are given this medicine. You may need to have a thorough examination and your treatment may need to be changed.

Using Brevibloc with other medicines

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription, including herbal products and supplements. Your doctor will check if any of the medicines you are taking can affect the way Brevibloc works.

In particular, tell your doctor, nurse, or pharmacist immediately if you are taking any of the following products:

• Medicines that can lower blood pressure or slow the heart rate
• Medicines used to treat arrhythmia or chest pain (angina) such as verapamil and diltiazem. You should not be given Brevibloc within 48 hours of your last dose of verapamil
• Medicines used to treat arrhythmia (such as quinidine, disopyramide, amiodarone) and heart failure (such as digoxin, digitoxin, digitalis,)
• Nifedipine, which is used to treat chest pain (angina), high blood pressure, and Raynaud's disease
• Medicines used to treat diabetes, including insulin and oral medicines
• Medicines known as ganglion blockers (such as trimetaphan)
• Medicines used as painkillers, such as non-steroidal anti-inflammatory drugs (NSAIDs)
• Floctafenine, which is a painkiller
• Amisulpride, a medicine used to treat mental problems
• Antidepressant medicines “tricyclic” (such as imipramine and amitriptiline) or any other medicine for mental health problems
• Barbiturates (such as phenobarbital, which is used to treat epilepsy) or phenothiazines (such as chlorpromazine, which is used to treat mental disorders)
• Clozapine, which is used to treat mental disorders
• Epinephrine, which is used to treat allergic reactions
• Medicines used to treat asthma
• Medicines used to treat colds or nasal congestion called “decongestants”
• Reserpine, which is used to treat high blood pressure
• Clonidine, which is used to treat high blood pressure and migraine
• Moxonidine, which is used to treat high blood pressure
• Derivatives of ergot, medicines that are often used to treat Parkinson's disease
• Warfarin, which is used as a blood thinner
• Morphine, which is a strong painkiller
• Suxamethonium chloride (also called succinylcholine or esculin) or mivacurium, which are used as muscle relaxants during an operation. Your doctor will also need to be careful when using Brevibloc during operations, when you are given anesthetics and other treatments.

If you are not sure if any of the above conditions apply to you, talk to your doctor, pharmacist, or nurse before using Brevibloc.

Checks that may be carried out while you are using Brevibloc

Using medicines like Brevibloc for a long time can reduce the strength of your heartbeats.

Since Brevibloc is only used for a limited time, it is unlikely that this will happen to you. During treatment, you will be closely monitored and treatment with Brevibloc will be reduced or stopped if the strength of your heartbeats decreases.

Your doctor will also be able to check your blood pressure while you are being treated with Brevibloc.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should not be given Brevibloc if you are pregnant or think you may be pregnant.

Tell your doctor if you are breast-feeding. Brevibloc can pass into breast milk and should not be given if you are breast-feeding

Important information about some of the ingredients of Brevibloc

Patients on low-sodium diets should note that this medicine contains 700 mg (30.45 mmol) of sodium per bag.

3. How Brevibloc will be given to you

Recommended dose

Your doctor will decide the dose of medicine you need and the length of treatment.

Brevibloc is not usually given for more than 24 hours.

How Brevibloc is given

Brevibloc is ready to use. It will be given to you through a slow injection (infusion) into a vein in your arm.

Brevibloc must not be mixed with sodium bicarbonate or any other medicine.

Treatment is given in two steps.

• Step one: a high dose is given over one minute. This will quickly increase the levels of Brevibloc in your blood.
• Step two: a lower dose is given over four minutes.
• Steps one and two can be repeated and adjusted according to how your heart responds. Once an improvement is seen, step one (the high dose) will be stopped and step two (the lower dose) will be reduced as needed.
• When a stable situation is reached, you may be given another heart medicine while the dose of Brevibloc is gradually reduced.
• If your heart rate or blood pressure increases during an operation or after the operation, you will be given higher doses of Brevibloc for a short period.

Elderly people

Your doctor will start treatment with a lower dose.

Children

Brevibloc should not be given to children under 18 years.

If you are given too much Brevibloc

If Brevibloc is given to you by a qualified person, it is unlikely that you will be given too much. However, if this does happen, your doctor will stop treatment with Brevibloc and, if necessary, give you additional treatment.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, Telephone 915 620 420, indicating the medicine and the amount administered.

If you think you have missed a dose of Brevibloc

If Brevibloc is given to you by a qualified person, it is unlikely that you will miss a dose. However, if you think you have missed a dose, talk to your doctor, pharmacist, or nurse as soon as possible.

If you stop using Brevibloc

Stopping treatment with Brevibloc suddenly can cause symptoms such as high heart rate (tachycardia) and high blood pressure (hypertension) to return. To avoid this, your doctor will stop treatment gradually. However, if you know you have coronary artery disease (which may be associated with angina or heart attack), your doctor will need to be careful when stopping treatment with Brevibloc.

If you have any further questions about the use of this product, ask your doctor, nurse, or pharmacist

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects disappear 30 minutes after stopping treatment with Brevibloc. The following side effects have been reported with Brevibloc:

If you notice any of the following side effects, which can be serious, tell your doctor, nurse, or pharmacist. The infusion will also need to be stopped.

Very common(may affect more than 1 in 10 people)

• Drop in blood pressure, which can be quickly corrected by reducing the dose of Brevibloc or stopping treatment. Your blood pressure will be checked frequently during treatment.
• Excessive sweating.

Common(may affect up to 1 in 10 people)

• Lack of appetite
• Feeling anxious or depressed
• Dizziness
• Drowsiness
• Headache
• Numbness or tingling
• Difficulty concentrating
• Feeling confused or agitated
• General discomfort (nausea and vomiting)
• Feeling weak
• Feeling tired (fatigue)
• Irritation and hardening of the skin at the injection site

Uncommon(may affect up to 1 in 100 people)

• Thought disorders
• Sudden loss of consciousness
• Feeling faint or fainting
• Seizures (fits or convulsions)
• Speech disorders
• Vision disorders
• Low heart rate
• Problems with the electrical impulses that control your heart rate
• High blood pressure in the arteries of the lungs
• Inability of the heart to pump enough blood (heart failure)
• Abnormal heart rhythm, sometimes known as palpitations (ventricular extrasystoles)
• Heart rhythm disorder (nodal rhythm)
• Chest discomfort caused by reduced blood flow through the blood vessels of the heart muscle (angina)
• Poor circulation in arms or legs
• Pale or reddened appearance
• Fluid in the lungs
• Difficulty breathing or pressure in the chest that makes breathing difficult
• Wheezing
• Stuffy nose
• Auscultation sounds
• Changes in taste
• Indigestion
• Constipation
• Dry mouth
• Stomach pain
• Discoloration of the skin
• Redness of the skin
• Pain in muscles or tendons, including those around the shoulders and ribs
• Difficulty urinating (urinary retention)
• Feeling cold or having a high temperature (fever)
• Pain and swelling (edema) of the vein where Brevibloc was injected
• Feeling of itching or bruising at the injection site

Rare(may affect up to 1 in 10,000 people)

• Severe decrease in heart rate (sinus arrest)
• Lack of electrical activity in the heart (asystole)
• Sensitive blood vessels with a area of reddened and hot skin (thrombophlebitis)
• Dead skin caused by leaks of solution around the injection site.

Frequency not known(cannot be estimated from the available data)

• High levels of potassium in the blood (hyperkalemia)
• High levels of acid in the body (metabolic acidosis)
• High heart rate (accelerated idioventricular rhythm)
• Spasm of the coronary artery
• Failure of normal blood circulation (cardiac arrest)
• Psoriasis (skin that produces scales).
• Swelling of the skin of the face, limbs, or tongue or swelling of the throat (angioedema)
• Hives (urticaria)
• Inflammation of a vein or blistering at the infusion site.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Brevibloc

• Keep this medicine out of the sight and reach of children
• Do not use Brevibloc after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not remove the overwrap until the time of use
• Do not store at a temperature above 25°C.
• Do not refrigerate or freeze
• The opened product is stable for 24 hours at 2-8°C. However, it should be used immediately once opened
• Do not use Brevibloc if you observe particles or discoloration in the solution

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE Collection Point (or any other pharmaceutical waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging contents and additional information

Composition of Brevibloc

• The active ingredient is esmolol hydrochloride. One ml contains 10 mg of esmolol hydrochloride. A 250 ml bag contains 2500 mg of esmolol hydrochloride.
• The other ingredients are: sodium acetate, glacial acetic acid, sodium chloride, and sterile water (referred to as "water for injectable preparations"). Sodium hydroxide or hydrochloric acid may be added to ensure a correct pH adjustment.

Appearance of Brevibloc and packaging contents

Brevibloc is a sterile, transparent, colorless or slightly yellowish solution for intravenous perfusion (slow injection). It is available in 250 ml plastic bags.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Baxter S.L.

Pouet de Camilo, 2

46394 Ribarroja del Turia (Valencia)

Manufacturer

Brevibloc in Viaflo bag is manufactured by

Vantive Manufacturing Limited

Moneen Road

Castlebar, Co. Mayo

F23 XR63, Ireland

Brevibloc in Intravia bag is manufactured by

Baxter SA

Boulevard René Branquart, 80

7860 Lessines

Belgium

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

CountryName

BelgiumBrevibloc 10 mg/ml, solution for perfusion

CyprusBrevibloc 10 mg/ml Διάλυμα για ενδοφλέβια έγχυση

DenmarkBrevibloc infusionsvæske, opløsning

FinlandBrevibloc 10 mg/ml infuusioneste, liuos

GermanyBrevibloc 10 mg/ml Infusionslösung

IrelandBrevibloc Premixed 10 mg/ml, Solution for Infusion

NetherlandsBrevibloc 10 mg/ml, oplossing voor infusie

NorwayBrevibloc 10 mg/ml, Infusjonsvæske, oppløsning

PortugalBrevibloc Premixed 10 mg/ml, Solução para perfusão

SpainBrevibloc 10 mg/ml solución para perfusión

SwedenBrevibloc 10 mg/ml, Infusionsvätska, lösning

United KingdomBrevibloc Premixed 10mg/ml, Solution for Infusion

(Northern Ireland)

Date of last revision of this prospectus November 2022.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Baxter, Brevibloc, Intravia, and Viaflo are registered trademarks of Baxter International Inc.